This invention generally relates to the field of surgery inside a collapsible body chamber and more particularly to a surgical apparatus for removing the lens from an eye.
The human eye in its simplest terms functions to provide vision by transmitting light through a clear outer portion called the cornea, and focusing the image by way of the lens onto the retina. The quality of the focused image depends on many factors including the size and shape of the eye, and the transparency of the cornea and lens. When age or disease causes the lens to become less transparent, vision deteriorates because of the diminished light which can be transmitted to the retina. This deficiency in the lens of the eye is medically known as a cataract. An accepted treatment for this condition is surgical removal of the lens and replacement of the lens function by an artificial intraocular lens (IOL).
Optical aberrations such as myopia, hyperopia, astigmatism and presbiopia can also be corrected by the removal of the natural lens of the eye and the implantation of a suitable IOL in a procedure known as refractive lens exchange identical to the cataract surgery procedure, except for the fact that the lens material is usually easier to remove. The best current standard of care procedure to remove cataractous lenses or perform a refractive lens exchange is a surgical technique called phacoemulsification. During this procedure, a hollow phacoemulsification probe is inserted into the eye through a small incision. The tip of the probe is placed in contact with the lens material and the tip is vibrated ultrasonically. The vibrating probe tip liquefies or emulsifies the lens material so that the lens content may be aspirated out of the eye. The lens content, once removed, is replaced by an artificial lens preferably placed inside the lens capsule bag.
A typical phacoemulsification surgical device suitable for ophthalmic procedures consists of an ultrasonically-driven hand piece, an attached hollow lensectomy probe, a surrounding coaxial irrigating sleeve and a control console. The hand piece assembly is attached to the control console by electric cables and by flexible tubing for irrigation and aspiration.
Through the electric cables, the control console provides power to the actuator in the hand piece that is transmitted to the attached lensectomy probe. The flexible tubing supplies irrigation fluid to and draws aspiration fluid from the eye through the hand piece assembly. Alternative methods for lens fragmentation currently available employ sonic wave, water jet and laser powered lens-disrupting hand pieces. The irrigation and aspiration systems of these alternative lens-removing methods typically operate similarly to standard ultrasonic phacoemulsification.
The operative part of ultrasonic hand pieces is a centrally located, hollow resonating bar or horn directly attached to a set of piezoelectric crystals. The crystals supply the required ultrasonic vibration needed to drive both the horn and the attached probe during phacoemulsification and are controlled by the console. The crystal/horn assembly is suspended within the hollow body or shell of the hand piece by flexible mountings. The hand piece body terminates in a reduced-diameter portion or nosecone at the body's distal end. The nosecone is externally threaded to accept the irrigation sleeve. Likewise, the horn bore is internally threaded at its distal end to receive the external threads of the probe. The irrigation sleeve also has an internally threaded bore that is screwed onto the external threads of the nosecone. The hollow probe is adjusted so that the probe tip projects only a predetermined amount past the open end of the irrigating sleeve. Ultrasonic hand pieces and cutting tips are more fully described in U.S. Pat. Nos. 3,589,363; 4,223,676; 4,246,902; 4,493,694; 4,515,583; 4,589,415; 4,609,368; 4,869,715; 4,922,902; 4,989,583; 5,154,694 and 5,359,996.
In use, the distal end of the lensectomy probe and irrigating sleeve are inserted into a small incision of predetermined width in the cornea, sclera, or other location. The probe tip is ultrasonically vibrated within the irrigating sleeve by the crystal-driven ultrasonic horn, thereby emulsifying the selected tissue in situ. The axis of vibration of the probe tip can be longitudinal, torsional or a combination. One of the advantages of the torsional system is reduced heat generation at wound level with reduced risk of incision thermal injury. The hollow bore of the probe communicates with the bore in the horn which in turn communicates to an aspirate-out port in the hand piece. A reduced pressure or vacuum source in the console draws or aspirates the emulsified tissue from the eye through the probe and horn bores and the flexible aspiration line and into a collection device.
The aspiration of emulsified tissue is aided by a flushing solution or irrigant that enters into the surgical site through the small annular gap between the inside surface of the irrigating sleeve and the outer surface of the probe. The flushing solution is typically a saline solution and enters the surgical site with a positive pressure created gravitationally or by forced infusion means, such as an adjustable pressurized gas source. Typical irrigation pressures are set between 40 and 130 cm H2O. The preferred surgical technique is to make the incision into the anterior chamber of the eye as small as possible in order to reduce the risk of induced astigmatism. To date these small incisions have had typical widths between 3.5 and 1.8 mm and result in very tight wounds that squeeze the coaxial irrigating sleeve tightly against the lensectomy probe. Friction between the coaxial irrigating sleeve and a vibrating probe generates heat, and probe overheating causing a burn to the tissue is avoided by the cooling effect of the aspirated fluid flowing inside the probe. Occasionally the probe tip becomes occluded with tissue, reducing circulation of the cooling aspirate and allowing the probe to build up heat with the risk of thermally damaging the incision.
An alternative technique called Micro Incision Cataract Surgery (MICS) has become popular as it allows further reductions of the incision dimensions. The main difference with this technique is that the irrigant is no longer delivered into the eye through a coaxial irrigating sleeve located surrounding the lens-disrupting hollow probe. With MICS a second irrigating instrument delivers the irrigant solution into the eye through a second small incision. The bare phacoemulsification probe is introduced without any surrounding sleeve through a tight, low leakage, micro-incision having a width in the range of 0.8 to 1.5 mm. The separate irrigating instrument is introduced through another incision having similar characteristics and dimensions. In this way, the MICS technique delivers the irrigant through a hollow instrument inserted into the eye through a second micro-incision. Aspiration of lens fragments and irrigant solution takes place through the aspiration channel of the hollow vibratory probe. The increasingly-small incisions currently used in the micro coaxial phacoemulsification technique as well as in the MICS technique limit the flow of irrigant into the eye determining the use of low aspirate flow rates to avoid a negative fluidic balance that can collapse the eye during surgery.
When fragments of cataractous tissue occlude the tip of the lensectomy probe, the aspiration pump remains operating and builds a vacuum in the aspiration line. This occlusion typically clears by the action of the built up vacuum aided by vibration of the lensectomy probe. An unwanted phenomenon known as post-occlusion surge can occur when the occlusion clears. This phenomenon results in a transient collapse of the anterior chamber of the eye typically lasting fractions of a second. Post-occlusion surge creates unstable surgical conditions such as anterior chamber shallowing, pupil contraction and corneal instability, all events which can lead to serious complications such as posterior capsule rupture, vitreous loss and lens luxation.
The events which lead to chamber instability are as follows: When the tip of the lensectomy probe becomes occluded by lens fragments, the vacuum that builds up inside the aspiration line contracts the walls of the elastic aspiration tubing. Also, the built up vacuum expands eventual bubbles circulating in the aspirate fluid. These two phenomena add up a volume void. Once the occlusion becomes cleared, the gradient between the positive pressure inside the eye chamber and the negative pressure inside the aspiration line determines a fast inrush of liquid circulating from within the eye chamber into the aspiration line through the now-cleared aspiration probe. This inrush ends after the contracted tubing walls re-expand and the expanded bubbles collapse due to the dropping vacuum. This inrush of liquid may exceed the rate of infusion of irrigant into the eye leading to a transient chamber collapse. As a mode of example, an occlusion break occurring at a vacuum level of 500 mmHg can produce a transient inrush of fluid at a flow rate above 80 ml/min during a fraction of a second. A transient chamber collapse will occur until the irrigation solution refills the eye chamber and dynamic fluidic equilibrium is restored.
Several strategies have been implemented to attempt diminish the chamber collapse that results from the post-occlusion surge phenomenon. To mention some: a) reduction of the maximum allowed vacuum level in the aspiration line, b) increase in the pressure of the irrigant solution, c) prevention of total occlusion by the incorporation of a small bypass port at the sidewall of the lensectomy probe, d) use of aspiration line tubing made from flexible but non-contracting polymers, e) use of high bore tubing in the irrigation line, f) splitting of the irrigation tubing to infuse the irrigant through two incisions, g) use of a particle retainer filter flowed by a narrow fluid passage in the aspiration line (Cruise Control System, Staar, USA), and h) predicting that an occlusion break will occur after a preset interval of occlusion (vacuum rise) and reversing operation of the aspiration pump to set a lower vacuum level before the occlusion actually breaks (CASE enabled, WhiteStar Signature System, AMO, USA). The method of increasing the pressure of irrigant solution delivered by an irrigation probe may indeed help to attenuate the magnitude of post-occlusion-break chamber collapses. However there is concern about using techniques that increase the irrigant pressure to reduce the post-occlusion surge phenomenon because of the risks of chamber instability, pupillary dilatation and contraction, ocular pain, hydration of the vitreous, optic nerve damage, herniated iris and others. Active infusion methods which pressurize the irrigant have been proposed but have the added risk of creating an overpressure inside the eye leading to serious complications.
Some U.S. pre-grant publications which help to define the general state of the art but do not anticipate or suggest the invention to be disclosed here include the following:
U.S. 2006-0078448 by Holden appears to disclose a system where sensing and venting are both performed at console level. Sensing performed near the handpiece, as will be seen herein, dramatically improves performance because of earlier detection of the occlusion break.
U.S. 2006-0173403 by Injev appears to disclose a proportional flow control system located inside a handpiece.
U.S. 2002-0151835 by Ross appears to disclose a pressure pulse on top of a vacuum inside an aspiration line.
U. S. 2006-0224163 by Sutton appears to disclose a surge cancelling method that partially blocks the aspiration line when an occlusion brake event is detected. This approach is not very effective because of the long period of OFF time required to compensate the void in the aspiration path using fluid from the eye flowing through the restricted aspiration channel.
Although many of the aforementioned techniques may help to reduce the problems associated with the post-occlusion surge phenomenon, the increasingly popular tendency to reduce the size of the incisions makes all these measures less effective. In fact post-occlusion surge is still a limiting factor to perform a more efficient lensectomy procedure, for example using higher vacuum levels what would allow removal of the lens using lower amounts of lens-disrupting energy such as ultrasound, in less time, with lower amounts of irrigant solution.
From a medical standpoint, it would be ideal to perform a lensectomy procedure using the lowest amounts of irrigant solution and the lowest amount of lens-disrupting energy. Both irrigant solution circulation and lens-disrupting energy are known to produce surgically induced trauma, such as endothelial cell loss. Therefore, a need continues to exist for an effective post-occlusion chamber collapse canceling system for a lens-removing surgical apparatus, especially to perform micro-incision cataract surgery.